Presented by Carl Norden, M.D. at the Anti-Infective Drugs Advisory Committee meeting on October 28, 2003

Study Exclusion Criteria - 1 §General conditions l Pregnant/breast-feeding women l Hypersensitivity to any of the main study antibiotics l Absolute neutrophil count <500/mm 3 l Enrollment in additional concurrent investigational protocol

Measuring Lesion Lesion or Ulcer Erythema Width Erythema Length Ulcer Length Ulcer Width Ulcer depth must also be measured

Wound Measurements

General Wound Parameters - 1

General Wound Parameters - 2

General Wound Parameters - 3

General Wound Parameters - 4

Total Wound Score

Wound Infection Score Circle the single most appropriate choice indicating your evaluation of the study diabetic ulcer regarding the above parameters. Patient should be in a sitting position for 3-5 minutes before these assessments are conducted.

Osteomyelitis Evaluation Visible bone, or [+ Probe to bone] X-ray characteristic for osteomyelitis X-ray compatible with osteomyelitis, or high clinical suspicion Treat as soft tissue infection Consider additional testing, eg, imaging MRI, or bone biopsy Repeat X-ray in 7-14 days Osteomyelitis – + + no yes no

Vasculopathy §Present in < ¾ of diabetic foot infections §Highly associated with ability to cure infection & to heal wound §Patients with non-critical ischemia may be enrolled in this study §Patients with potentially critical ischemia may be enrolled- if approved by vascular consultant

Vascular Evaluation History of claudication at < 1 block walking Neither DP nor PT pulse palpable Doppler evaluation (wave form analysis) Ankle/Brachial BP <0.5 Toe BP <30 Ankle BP <50 T c pO 2 <30 No vascular evaluation required Consider vascular evaluation no yes

Assessing Efficacy §Primary assessment is clinical outcome l assessed at days 7, 14, 21, iv  po switch l determined at EOT and FU visits §Criteria for assessment l Cured : resolution of all pre-therapy signs & symptoms of infection; wound healing l Improved : resolution of >2 but not all infection signs & symptoms; only at EOT l Failed : persistence/progression baseline signs/sx infection or new clinical findings l Indeterminate : extenuating circumstances preclude classification

Microbiology § S. aureus (MSSA and MRSA) §ß-hemolytic streptococci §Coagulase-negative staphylococci